Breakout Session with Feedback to Consider How QbD and Science-Based Drug Design Might be Reduced to Practice

1:00—2:00

Lunch

2:00—2:45

Factors Affecting Drug Absorption Dr. Gino Martini (GB)

2:45—3:30

Science-Based Stability Considerations Dr. Patrick Crowley (USA)

3:30—4:00

Coffee Break

4:00—4:30

Drug-Excipient Interactions Dr. Patrick Crowley (USA)

4:30—5:00

Are GMP and QbD Compatible and What Needs to Change? Discussion by Participants

Chairs and Speakers

Prof. Dr. Abdulla Molokhia is Chairman, EEPI, Pharco Pharmaceuticals, Alexandria, Egypt. He held academic positions at Universities of Houston, Riyadh, Alexandria, and is a consultant to the WHO. He co-authored more than 120 original manuscripts, and presentations. He was the chairman of the Egyptian National Organization for Drug Control and Research, 1996-2004.

Prof. Dr. Omar El-Ahmady is director of R&D and Quality; and member of the board of EIPICO, Egypt. As a professor of Biochemistry and Emeritus dean of college of pharmacy, Al Azhar University, he founded the tumor markers research center and advised/co-advised more than 100 M.S. and Ph.D. students. He published more than 140 publications and presented more than 200 international presentations to conferences all over the world. He received many awards including the Egyptian National Award in Biological Sciences.

Dr. Rania Salama is a Post Doctorate Fellow in Pharmaceutics at the Faculty of Pharmacy, University of Sydney. Her research expertise is in inhalation medicine, with a specific interest in controlled release formulations, in vitro/in vivo methodologies and correlations. To date, Rania has published 20 research articles and conference proceedings, including 6 peer review articles since 2007.

Dr. Paul M. Young is an Associate Professor at the Faculty of Pharmacy, University of Sydney. Paul has published 70 peer reviewed international journal articles (>400 citations), 5 patents, 9 book chapters and in excess of 80 conference proceedings. In addition, Paul has given invited conference seminars on multiple occasions.

Dr. Daniela Traini is Senior Lecturer at The University of Sydney, Faculty of Pharmacy. Daniela scientific interests include surface energy and particle interactions; characterisation and optimisation of pharmaceutical materials specifically for aerosol drug delivery and correlations with in vivo applications. To date, Daniela has 44 publications, 4 invited reviews, one book chapter, 3 patents and 17 extended conference proceedings.

Engineer Fadhel Belaiba is the regional commercial director at Harro Höfliger, his tasks consist of understanding the customer requirements and providing them with an individual solution during all phases, from process development, machine development & building, stability samples to product launch. He studied Business and Technical Engineering at the University of Cologne.

Dr Alaa Eldeen Yassin is an associate professor of pharmaceutics at King Saud University, KSA. His research interests focus on oral drug delivery with emphasis on colonic, gastro-retentive; and nanoscale systems for the delivery of anticancer drugs. He is the recipient of the Teaching & Research Excellency Awards from KSU (2009). Dr. Yassin has obtained his Ph.D. degree in Pharmaceutics, University of Wisconsin-Madison under the supervision of Prof. Joseph Robinson. He has more than 40 publications and international conference presentations.

Dr. Silvia Kocova El-Arini supervises postgraduate students at NRC, Cairo, and at the University of Tuzla and is advisor to the pharmaceutical industry of Bosnia. She taught at the American University in Cairo and was affiliated with FDA and University of Basel. She served as UN consultant and held posts at Bayer and Merck. She is co-author of two book chapters, many publications and presentations.

Prof. Dr. Uday Kompella is Professor of Pharmaceutical Sciences at University of Colorado Denver. Dr. Kompella’s research interests include development of drug and gene delivery systems for treating neovascular disorders such as diabetic retinopathy, age related macular degeneration, corneal angiogenesis, lung cancer, and prostate cancer. He has authored/co-authored over 100 scientific papers and book chapters and co-edited two books. He is an editor for the journal, “Pharmaceutical Research”. Also, he is an editorial board member for five other journals. Dr. Kompella was honored with the “AAPS Fellow” status.

Dr. Sarah Molokhia is a post doctorate at the Moran Eye center, Salt Lake City, Utah. She is currently working on a novel intraocular drug device, soon going for clinical trials. She received her PhD in Pharmaceutics, University of Utah with focus on transscleral iontophoresis, ocular imaging and ocular pharmacokinetics.

Dr. Patrick Crowley was the Vice President of Pharmaceutical Development at GlaxoSmithKline, USA. During his career, he was involved in the development of 15 commercial products containing novel chemical entities, fermentation products, semi synthetics and a Biopharmacy material. Since retiring he is an independent consultant and holds lectureship positions at a number of institutes and is an Examiner for the MSc Courses.

Dr. Gino Martini is currently Senior Director in Asia Pacific, Japan and Emerging Markets Business Unit within R&D. at GlaxoSmithKline. Dr. Martini is a Visiting Professor at John Moores Liverpool University School of Pharmacy and a Visiting Lecturer at Kings College London School of Pharmacy. He was designated a Fellow of the Royal Pharmaceutical Society of Great Britain in 2008.
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